CAMMS03409 Version 1.0

• Research type

  Research Study

• Full title

  An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab.

• IRAS ID

  23387

• Eudract number

  2009-010788-18

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This extension study is being conducted to evaluate patients who have already participated in one of Genzymes's previous studies with Alemtuzumab (CAMMS 223, 323 and 324). This study will examine the long term safety and effectiveness of alemtuzumab in patients who received alemtuzumab during these prior studies (mentioned above), the safety and efficacy of alemtuzumab retreatment (subject to meeting defined criteria) in these previously alemtuzumab-treated patients and the safety and efficacy of two fixed annual alemtuzumab cycles followed by optional retreatment (subject to meeting defined criteria) in patients who were previously treated with interferon beta-1a, during these prior studies.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  09/H1211/72

• Date of REC Opinion

  1 Jul 2009

• REC opinion

  Favourable Opinion